The present invention relates to an irrigation device comprising a reservoir for an irrigating liquid, a catheter in fluid communication with the reservoir, a fixation member, and a control unit arranged for in a first position transferring the irrigation liquid to the fixation member and in a second position transferring the irrigation liquid to the catheter.
Administrating an irrigation liquid is a common medical procedure whereby liquid is injected into the rectum and lower intestine of a patient in order to induce bowel movement. The need for such a procedure typically arises in patients suffering from certain physical ailments in which voluntary bowel control is impaired or when the bowel needs to be cleaned before e.g. a coloscopy or a surgical operation.
Medical equipment currently exists in the art for administering an irrigation liquid to patients in need of this procedure, e.g. from international patent publication no. WO 98/23312, where the irrigation medium is fed by gravity from a bag hung from a frame arranged close to the patient. As the operation is dependent on gravity, the system cannot be readily portable, which is often very important if the patient should lead a normal life.
Although some conventional systems are mobile, they are heavy and cumbersome, and are thus not readily transportable by the user. Consequently, they tend to be restricted to use in hospitals or nursing homes.
However, irrigation liquids often needs to be administered to a patient at home when the need for medical assistance does not necessitate a doctor or another health care assistant. In this respect it is often difficult for the patient to administer the irrigation liquid to himself or herself since the conventional irrigation devices often causes discomfort and irritation when being inserted. Moreover, it is difficult for the patient to administer the liquid while steadily holding the irrigation liquid in the required area. Often another individual assists the patient but assistance may not always be available, if for instance, the patient lives alone. Thus there is also a need for an irrigation device that effectively can be used for self-administration of irrigation liquids.
The self-administration of irrigation liquids using the conventional irrigation systems may furthermore be especially difficult for elderly or patients having physical problems, not only due to the complexity of the systems but also since the systems require the use of many different components to work together. The catheter needs to be inserted, the pump must be activated and the correct dose of liquid must be delivered.
Although it at first sight would be advantageous simply to make a very simple device without e.g. a pump and/or other control units, such modifications may adversely affect other desirable features of the device. In particular, it is desirable to prevent any reflux of liquid back into the reservoir after the irrigation liquid has been delivered, and it is desirable to ensure that the catheter is correctly keep in place during the addition of irrigation fluid to the body cavity. A simplification of the device may compromise these features.
In order to meet some of the drawbacks with the known irrigation systems, U.S. Pat. No. 5,074,842 describes an irrigation system, which comprises a tube and a balloon for retaining the tube in the rectum. Said balloon can be inflated after the insertion of the tube. The balloon is inflated using air, which is delivered through a syringe valve which communicates with an air passage. A similar system is known from European patent publication no. 1531885, which describes an irrigation system comprising a reservoir, and an air inflated balloon for fixation of a tube in the rectum.
Even thought the balloon in these known systems will assist the patient by helping to keep the catheter in the correct place during the irrigation, the systems have the major drawback that the balloon cannot safely keep the tube in place during use due to the fact that the air filled balloon reacts to the body movements, e.g. peristaltic reflexes, resulting in that the catheter inconveniently may fall out of the body cavity. This is not only unwelcoming for the patient but also very demeaning, as the surroundings inevitability will be contaminated with irrigation liquid and bodily fluids.
Furthermore, since air is used to inflate the balloon in these known systems, additional elements are needed in the systems in order to ensure that the air can be delivered to the surroundings instead of into the body cavity. If the air was delivered at the body cavity this would result in an additional distending or dilation of said body cavity resulting in additional pain and discomfort for the patient.
International patent publication no. WO 2009/080050 relates to a probe for use in connection with anal irrigation. Said prove comprises a tip part, a shaft part and an expandable balloon for retaining the probe in the rectum. The balloon is connected to the probe in such a way that when irrigation liquid is added to the probe the balloon starts to expand. This expansion will continue until the maximum expansion is achieved at which point the tip part and shaft part will start to be dislodged in relation to each other providing a flow path between the reservoir and the tip part. In order for an irrigation to take place, the complete volume of irrigation liquid will have to pass through the expandable balloon. Said balloon will continually expand which can lead to great discomfort and pain for the user. Furthermore, as all irrigation liquid has to pass the balloon it is not possible to e.g. minimize the expansion of the balloon during use.
From British patent publication no. 191107078 is also known an irrigation device comprising a probe and a retaining member, which can expand using irrigation liquid. However when the extended retaining member is to be emptied, this will have to be performed by disconnecting the device to the supply of irrigation liquid and allowing a backflow of liquid from the expanded retaining member either unrestricted into the surroundings, leading to contamination of the surroundings, or alternatively back into the reservoir of irrigation liquid, leading to contamination of the reservoir. Furthermore, the device in GB191107078 comprises no means for preventing backflow from the site of irrigation during use.